Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma
Intraocular Melanoma, Melanoma (Skin)

About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring iris melanoma, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Unresectable stage III or stage IV disease Ocular, mucosal, or cutaneous melanoma Measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of severe cardiovascular disease No myocardial infarction within the past 6 months No unstable angina No New York Heart Association class III or IV heart disease (congestive heart failure) No ventricular tachyarrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No AIDS-related illness No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) No serious infection requiring IV antibiotics No psychiatric disorder requiring ongoing therapy or medication No nonmalignant illness or other medical condition that would preclude study No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy and recovered No concurrent immunotherapy Chemotherapy: No prior dacarbazine No prior temozolomide No other concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery At least 3 weeks since prior radiotherapy to the brain for brain metastases Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered
Sites / Locations
- Memorial Sloan-Kettering Cancer Center